Wednesday, July 06, 2016

Significant changes in the MACRA regulations proposed by CMS are necessary for encouraging the development and implementation of Alternative Payment Models, but regulatory changes alone are not sufficient. The processes that CMS currently uses to implement APMs are far too slow and burdensome to achieve Congress’s goal of enabling as many physicians as possible to participate in APMs. CMS must create better, faster ways to implement Alternative Payment Models that meet the requirements of the law and regulations.

How CMS Should Improve Its Processes for Implementing APMs

Although the Affordable Care Act created the Center for Medicare and Medicaid Innovation in 2010 in order to accelerate the development and implementation of innovative payment and delivery models, relatively little progress has been made in improving the ways most physicians and other providers are paid for their services. As the American Medical Association has stated, “Five years after CMS was authorized to implement ‘new patient care models’…Medicare still does not enable the majority of physicians to pursue …opportunities to improve care in ways that could also reduce costs. Today, despite all of the demonstration projects and other initiatives that Medicare has implemented, most physicians – in primary care and other specialties – still do not have access to Medicare payment models that provide the resources and flexibility they need to improve care for their Medicare patients. Consequently, most Medicare patients still are not benefiting from regular access to a full range of care coordination services, coordinated treatment planning by primary care and specialist physicians, support for patient self-management of their chronic conditions, proactive outreach to ensure that high-risk patients get preventive care, or patient decision-support tools. As a result, the Medicare program is paying for hospitalizations and duplicative services that could have been avoided had physicians been able to deliver these high-value services.”

Creating a More Efficient Approach to Implementing APMs at HHS

One key reason for this slow progress is that the Center for Medicare and Medicaid Innovation (CMMI) has created a far more complex and resource-intensive process than is required or necessary to implement alternative payment models. Under most of the payment demonstrations that it has implemented to date, 18 months or more have elapsed from the time an initiative is first announced to the time when providers actually begin to receive different payments. Moreover, many proposals for alternative payment models have been submitted to CMMI that have not been implemented. This is not because the staff at CMMI are slow or incompetent, but because of the complex, expensive, and time-intensive process they have created for designing the initiative, selecting participants, managing the payments, and evaluating the results as part of any payment model they test.

This process is extremely burdensome and expensive for CMMI to administer, it dramatically reduces the number of alternative payment models that can be tested, and it is also extremely burdensome for providers who are interested in participating in the initiatives that CMMI does attempt to implement. Many providers have decided not to even apply to participate in otherwise desirable CMMI programs and others have dropped out of the programs in the early phases solely or partly because of the cost and time burden of participating.

This burdensome process is not required by either the Affordable Care Act or MACRA. If HHS were to attempt to implement every new alternative payment model using the approaches that are currently being used by CMMI, it would take many years before even a fraction of the physicians in the country would have the ability to meet the APM requirements under MACRA. This would mean relatively few Medicare beneficiaries could benefit from the higher quality care that would be possible under APMs and the Medicare program would not achieve the savings that APMs could generate. This is clearly not what Congress intended either in the Affordable Care Act or in MACRA.

A complete re-engineering of the processes HHS uses to implement alternative payment models is needed. This re-engineering process should start with the goal that is implicit in MACRA – every physician should have the opportunity to receive at least 25% of their Medicare revenues from alternative payment models in 2019, 50% of their revenues in 2021, and 75% in 2023. HHS should then work backward from those dates and design processes and timetables for implementing APMs in every medical specialty that will achieve that goal.

Just as many physicians, hospitals, and other healthcare providers are now re-engineering their care delivery processes to eliminate steps that do not add significant value, HHS should use Lean design techniques and other approaches to identify and eliminate all steps and requirements in its implementation processes that do not add value or that impede achieving the goals that Congress has set. Moreover, since MACRA allows alternative payment models to be implemented using statutory authorizations other than Section 1115A (the enabling legislation for CMMI), HHS should use all of the options available under MACRA in order to implement desirable alternative payment models in the most efficient way possible.

In order for a physician to be participating in an APM during 2019, the processes for approving and implementing the APM and for approving the physician’s participation in the APM will have to be completed no later than the end of 2018. However, in order for physicians to succeed under APMs, they will need to have sufficient lead time to form or join an alternative payment entity and to redesign the processes by which they deliver care with the flexibility provided by the APM, and so both the structure of the APM and the approval for a physician’s participation will need to be completed long before the end of 2018. Some physician groups and medical specialty societies have already developed physician-focused alternative payment models that should be able to meet the criteria under MACRA; these could and should be implemented by CMS as soon as 2017.

To ensure that the MACRA goals are achieved, HHS should establish specific milestones that are designed to implement as many alternative payment models as possible and as quickly as possible. For example, the following timetable would allow payments under an alternative payment model to begin flowing to a physician within one year after the model is recommended by the PTAC:

When a physician-focused alternative payment model is recommended for implementation by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) that was created by Congress under MACRA, CMS should plan to implement it unless there is a compelling reason not to do so. The decision to implement the model should be made within 60 days after it is recommended by the PTAC.

Once a physician-focused alternative payment model is recommended by the PTAC and approved by HHS, the applications that physician practices and alternative payment entities would need to complete in order to participate in the approved APM should be made available within 90 days.

Physicians and alternative payment entities should be permitted to apply to participate in an approved APM no less frequently than twice per year.

Applications to participate in an approved APM should be reviewed and approved or rejected within 60 days. Applications should only be rejected if an applicant cannot demonstrate that it has the ability to implement the model, not because of arbitrary limits on the size of the program or the locations where providers can be located. If an application is rejected, CMS should provide feedback to the applicant on the reasons for rejection and methods of correction. If a rejected application is revised and resubmitted, CMS should re-review it and approve or reject it within 30 days.

CMS should implement an approved APM with the approved physician applicants no later than 90 days after the applications by physician practices to participate have been approved.

Once a physician or other clinician begins to participate in an APM, they should be permitted to continue doing so as long as they wish to, unless CMS can demonstrate that Medicare spending under the payment model is higher than it would be under the standard physician fee schedule or that the quality of care for beneficiaries is being harmed.

Creating the Capability at HHS to Implement a Broad Range of Physician-Focused APMs

A second key reason why only a small number of physicians are participating in alternative payment models under Medicare is the problematic structure of the current models that CMS and CMMI have been using. Most of the payment models that are currently being implemented or tested by CMS use a very similar approach – no changes in the current fee for service structure, holding individual physicians accountable for the costs of all services their patients receive from all providers, adjusting payment amounts based on shared savings calculations for attributed patients, etc. – and these approaches not only fail to solve the problems in the current payment systems, they can actually make them worse.

The components used in most CMS payment models are very problematic for physicians and therefore they are likely problematic for their patients as well. Although CMS may view some of these payment models as “physician-focused” because they are targeted at individual physicians or physician practices, the goal should be to create physician-focused payment models that are successful in improving care and improving costs in ways that are feasible for physician practices, particularly small practices, to implement. To date, the alternative payment models implemented by CMS have not been successful in reducing costs because they do not provide the kinds of support that physicians need to redesign care. New physician-focused payment models should not be required to use the same flawed approaches that are being used in current CMS payment demonstrations.

At a minimum, HHS should create the administrative capabilities to implement seven different types of physician-focused APMs that can be used to address the most common types of opportunities and barriers that exist across all physician specialties. These are:

Payment for a High-Value Service. Under this APM, a physician practice could be paid for delivering one or more desirable services that are not currently billable, and the physician would take accountability for controlling the use of other, avoidable services for their patients.

Condition-Based Payment for Physician Services. Under this APM, a physician practice would have the flexibility to use the diagnostic or treatment options that address a patient’s condition most efficiently and effectively without concern that using lower-cost options would harm the operating margins of the physician’s practice.

Multi-Physician Bundled Payment. Under this APM, two or more physician practices that are providing complementary diagnostic or treatment services to a patient would have the flexibility to redesign those services in ways that would enable high-quality care to be delivered as efficiently as possible.

Physician-Facility Procedure Bundle. This APM would allow a physician who delivers a procedure at a hospital or other facility to choose the most appropriate facility for the treatment and to give the physician and facility the flexibility to deliver the procedure in the most efficient and high-quality way.

Warrantied Payment for Physician Services. This APM would give a physician the flexibility and accountability to deliver care with as low a rate of complications as possible.

Episode Payment for a Procedure. This APM would enable a physician who is delivering a particular procedure to work collaboratively with the other providers delivering services related to the procedure (e.g., the facility where the procedure is performed, other physicians who are involved in the procedure, physicians and facilities who are involved in the patient’s recovery or in treating complications of the procedure, etc.) in order to improve outcomes and control the total spending associated with the procedure.

Condition-Based Payment. Under this APM, a physician practice would have the flexibility to use the diagnosis or treatment options that address a particular health condition (or combination of conditions) most efficiently and effectively and to work collaboratively with other providers who deliver services for the patient’s condition in order to improve outcomes and control the total spending associated with care for the condition.

More detail on each of these physician-focused Alternative Payment Models and examples of how they could be used to improve care for a wide range of patient conditions is available in a report developed by CHQPR and the American Medical Association entitled A Guide to Physician-Focused Alternative Payment Models (available at www.CHQPR.org).

HHS should begin immediately to implement the administrative systems needed to support all of these types of payment models. This would not only ensure that the APMs can be implemented by 2019, but it would encourage physician groups and medical specialty societies to design payment models in a common framework, which will reduce implementation costs for HHS.

Re-engineering the processes for implementing alternative payment models as discussed above should dramatically increase the capacity of HHS to implement more payment models more quickly than it can today. However, if there are insufficient staff or resources at HHS/CMS/CMMI to support implementation of a sufficient number of new alternative payment models to enable all physicians to participate, additional resources should be provided to achieve the necessary “bandwidth.” Failing to allocate sufficient resources to implement alternative payment models that will save money for the Medicare program would be “penny wise and pound foolish.”

Greater Accountability is Needed by CMS As Well As Physicians

It would obviously be a tremendous waste of time and energy for physician groups, medical specialty societies, and others to develop alternative payment models that meet the requirements of the regulations if they will not be implemented by CMS. Consequently, it will be essential that CMS create the necessary systems and processes so that it can implement alternative payment models that meet the statutory and regulatory requirements. MACRA and the implementing regulations significantly increase the accountability that physicians will need to accept in return for payment.CMS needs to make comparable commitments to greater accountability for improving its own efficiency and effectiveness in designing and implementing new payment models.

(The points above as well as additional comments on the proposed MACRA regulations are included in the Center for Healthcare Quality and Payment Reform’s formal comment letter to CMS on the proposed MACRA regulations, which can be downloaded here.)

Tuesday, July 05, 2016

Thousands of comments were filed last week on the proposed regulations to implement the provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). One of the most important decisions CMS will need to make in finalizing the regulations is how to revise the proposed criteria for APMs.

How CMS Should Define Criteria for APMs that Match Congressional Intent

In MACRA, Congress clearly intended to encourage the development and implementation of Alternative Payment Models. It created significant incentives for physicians who participate in APMs at a minimum level, including:

Exempting them from MIPS

Awarding them a 5% lump sum bonus for six years

Giving them a higher annual update (increase) in their FFS revenues

These incentives are in addition to the benefits of participating in the APM itself.

Congress also clearly intended to encourage the development and implementation of APMs by establishing a very small number of very basic requirements for the APMs that would qualify for these incentives:

the APMs should involve more than nominal financial risk;

the APMs should use quality measures comparable to MIPS; and

the APMs should use certified EHR technology.

Unfortunately, in the proposed regulations, CMS went far beyond what Congress proposed, labeling the APMs to which the incentives would apply as “advanced” APMs and defining the Congressional criteria in very burdensome and restrictive ways. If the proposed regulations were implemented, they would serve as a serious barrier to progress in designing, implementing, and encouraging physician participation in Alternative Payment Models, which is completely counter to what Congress intended.

Congress did not use the term “advanced” to describe alternative payment models, nor did it in any fashion indicate that physicians should only be rewarded for participating in a narrowly defined subset of “advanced” Alternative Payment Models. The final regulations need to be significantly revised so they do what was envisioned by Congress – accelerate the implementation of successful Alternative Payment Models.

MACRA requires that in order for a physician to be exempt from MIPS and to qualify for the bonus payments and higher updates authorized by Congress, the alternative payment entity (i.e., the organizational entity that is actually receiving payments under the alternative payment model) must bear “financial risk for monetary losses under … [an] … alternative payment model that are in excess of a nominal amount.” The term “financial risk for monetary losses” in MACRA clearly refers to losses in the operations of the alternative payment entity, not to losses or increased spending in the Medicare program. However, in the proposed regulations, CMS defined risk for all but small primary care practices in terms of Medicare spending.

It is inappropriate to measure the amount of risk accepted by a physician practice or other provider in terms of the percentage change in total Medicare spending on the practice’s patients because (a) even a small percentage of Medicare spending can exceed the total revenues of a physician practice, and (b) the ratio of Medicare spending to physician practice revenues varies dramatically from specialty to specialty.

Under the proposed regulations, for most types of physician practices and APMs, CMS would require that an alternative payment entity be at risk for at least 4% of total Medicare spending in order for the participating physicians to qualify for the Congressional incentives. Since payments to physicians currently represent about 19% of total Medicare Part A and Part B spending, requiring them to pay CMS for up to 4% of Medicare spending would represent, on average, a payment of more than 20% of the physician practice’s revenue. Causing a physician practice to lose 20% of its revenue is clearly far “more than nominal” risk – it is significant financial risk.

Although payments to physician represent 19% of Medicare spending on average, for many physician practices, their revenues represent a much smaller percentage of total Medicare spending on their patients. In many cases, a physician practice’s revenues may represent less than 5% of total Medicare spending on their patients. For these practices, a 4% change in Medicare spending could represent 100% or more of the practice’s revenues. A physician practice could be forced out of business if it is held responsible for paying for even a very small percentage change in the total Medicare spending for the practice’s patients. Moreover, the fact that 4% of Medicare spending represents a higher amount relative to physician practice revenues for different specialties would mean that physicians in different specialties would face different levels of risk to participate in APMs, and there is no indication that Congress intended that.

It seems quite clear that in using the term “more than nominal financial risk,” Congress did not mean “significant” financial risk or it would have used that term in the law. In is inappropriate for CMS to issue regulations that are so clearly at odds with Congressional intent.

However, CMS has defined the solution to this problem in the proposed regulations. The proposed regulations created a separate definition of risk for small primary care practices participating in medical home programs that is based on a percentage of their revenues, not a percentage of Medicare spending. There is no reason to limit this approach just to small primary care practices or medical home programs. All physician practices should have their risk defined in terms of the amount of their revenues they could lose, rather than the percentage of Medicare spending they would be required to pay.

Risk is Created by Unreimbursed Costs as Well as Reductions in Payment

Basing risk on a practice’s revenues only solves part of the problem with the regulations, however. The financial risk incurred by an alternative payment entity is a function of the costs that the alternative payment entity incurs to implement the alternative payment model as well as the revenues it receives under the model. If the alternative payment entity hires or pays for new staff to deliver services to patients under the alternative payment model, if it acquires new or different equipment to deliver services, or if it incurs other kinds of expenses to implement the alternative payment model, and if those expenses are not automatically or directly reimbursed by Medicare, then the alternative payment entity is accepting financial risk for monetary losses.

One of the reasons for creating APMs is that Medicare does not currently pay physicians for many services that would benefit patients and help reduce avoidable spending. For example, there is generally no payment or inadequate payment for:

responding to a patient’s phone call about a symptom or problem, even though that could help the patient avoid the need for far more expensive services, such as an emergency department visit;

communications between primary care physicians and specialists to coordinate care, even though that type of communication and coordination can avoid ordering of duplicate tests and prescribing conflicting medications;

communications between community physicians and emergency physicians, even though that could enable patients to be safely discharged without admission;

time spent by a physician serving as the leader of a multi-physician care team for patients with complex conditions;

providing proactive telephone outreach to high-risk patients to ensure they get preventive care, even though that could prevent serious health problems or identify them at earlier stages when they can be treated more successfully;

spending time in a shared decision-making process with patients and family members when there are multiple treatment options, even though that has been shown to reduce the frequency of invasive procedures and the use of low-value treatments;

hiring nurses and other staff to provide education and self-management support to patients and family members, even though that could help them manage their health problems more effectively and avoid hospitalizations for exacerbations;

providing palliative care for patients in conjunction with treatment, even though that can improve quality of life for patients and reduce the use of expensive treatments; and

providing non-health care services (such as transportation to help patients visit the physician’s office), even if those services would avoid the need for more expensive medical services (such as the patient being taken by ambulance to an emergency department).

If an alternative payment entity implemented these kinds of services under an alternative payment model in order to help improve outcomes for its patients and reduce Medicare spending, it could easily incur monetary losses even Medicare has achieved savings. For example, even under an “upside only” shared savings model, a physician practice or other provider incurs financial risk if it incurs costs to deliver services to beneficiaries that are designed to reduce Medicare spending, since the provider could fail to qualify for the shared savings payment it needs to pay for those costs even when Medicare spending has been reduced.

Consequently, financial risk cannot be defined simply in terms of the potential reduction in revenues the alternative payment entity could receive from Medicare. An alternative payment entity’s “financial risk for monetary losses” under an alternative payment model should be defined as the potential difference between the amount of costs the entity incurs or is obligated to pay as part of the alternative payment model and the amount of revenues that it could receive under the APM. The greater the costs it incurs or the lower the revenue it could potentially receive, the greater the financial risk it will face under the APM.

Setting a Reasonable Threshold for “More Than Nominal”

Although many people seem to think that “financial risk” is only associated with alternative payment models, there is financial risk involved in any payment system other than one which reimburses physicians or other providers for their actual costs. Today, physician practices incur financial risk for monetary losses under the fee-for-service payment system because the costs they incur for office space, equipment, and staff are not directly reimbursed by Medicare, and if the practice does not deliver enough services to generate fee-for-service payment revenues in excess of those costs, it could be forced to declare bankruptcy. The measure of a good alternative payment model should not be how much it increases financial risk for physician practices and other providers, but rather how effectively it realigns their financial risk so that financial losses result from delivering lower quality care rather than from delivering fewer services.

In MACRA, Congress has placed all physicians’ payments “at risk” under the Merit-Based Incentive Payment System (MIPS). In the initial year of the program (2019), physician payments could be reduced by 4%, and the maximum reduction increases to 9% in 2022. These amounts are presumably “more than nominal” if Congress expected them to influence physician performance on the measures defined in MIPS, which includes resource measures.

Consequently, “more than nominal” risk for APMs could be defined using the maximum reduction amounts that are used in MIPS. In 2019, since a physician’s payments could be reduced by 4% under MIPS even with no change in the physician’s costs, an alternative payment entity should be viewed as being at “more than nominal financial risk” if the amount of costs that it incurs under an alternative payment model could exceed the amount of revenue it receives under the model by at least 4%.

Use of Quality Measures

In addition to requiring minimum levels of financial risk, MACRA requires that an APM “provide for payment for covered professional services based on quality measures.” It does not require that the amounts of payment be a “factor” in determining the amount of payment, as CMS has proposed in the regulations. This excessively narrow interpretation of the MACRA requirements in the proposed regulations led CMS to declare that one of its most widely used and potentially successful programs – the Bundled Payments for Care Improvement (BPCI) program – would not qualify as an APM under MACRA.

If a payment model is designed to achieve savings, the Affordable Care Act requires only that the payment model do so “without reducing the quality of care.” Consequently, an APM should be considered a qualified alternative payment model if it (1) measures quality and (2) requires a minimum standard of quality to be met in order for physicians to continue to participate in the APM. This would allow a much broader range of current and future APMs to qualify.

Use of EHR Technology

In addition to the provisions regarding financial risk and quality, MACRA requires that participants in an alternative payment model “use” certified EHR technology. After several years of HHS trying to define “meaningful use” of EHRs, there is widespread agreement that detailed requirements regarding how clinicians should use EHRs have increased costs and harmed quality rather than improving it. Since MACRA simply requires “use” of the EHR, regulations regarding use of EHRs in APMs should only require that clinical data about the patients receiving care as part of the alternative payment model be stored in a certified electronic health record system. It is impossible to prescribe how a physician or other provider should “use” the technology beyond this without potentially interfering with the provider’s flexibility to deliver services in the most effective way or imposing unnecessary costs and administrative burdens on the provider. A physician practice participating in the APM will have a strong incentive to use the EHR if the EHR has capabilities that will improve the practice’s success, regardless of any specific requirements imposed by HHS. Any specific requirements for “use” of EHRs that are imposed in regulations should be treated as a cost that increases the financial risk for a physician practice to participate in the APM if the cost is not explicitly supported by the APM itself.

What the Final Regulations Should Say

The final regulations should not label APMs that meet the Congressional criteria as “advanced” APMs, they should define “more than nominal risk” based on a reasonable percentage of a practice’s costs and revenues, and they should establish more reasonable and flexible requirements for quality measures and EHR use. To do this, the final regulations could be revised to read as follows:

414.1415 Qualified APM criteria

(a) Use of certified electronic health record technology. The following constitutes use of CEHRT:

**

(2) Required use of certified EHR technology. To be a Qualified APM, an APM Entity must store clinical data in CEHRT regarding the care delivered to patients with financial support from the APM.

***

(b) Payment based on quality measures.

(1) To be a Qualified APM, an APM must ensure that the quality of care for patients receiving services under the APM is maintained or improved.

***

(c) Financial risk. To be a Qualified APM, an APM must either meet both the financial risk standard and nominal risk standard described in this section or be an expanded Medical Home Model as described in paragraph (c)(5) of this section.

(1) Financial risk standard. To be a Qualified APM, an APM must, based on whether an APM Entity’s actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified performance period, do one or more of the following:

(i) Withhold payment for services to the APM Entity or the APM Entity’s eligible clinicians;

(iv) Cause the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.

(2) Nominal amount standard. To be a Qualified APM, either:

(i) the minimum total annual amount that an APM Entity must potentially owe or forego under the APM must be at least 4 percent of the APM Entity’s total Medicare Parts A and B revenue, or

(ii) the APM entity must document that (a) it is using its own resources to deliver new or expanded services to beneficiaries that are not directly paid for by Medicare and (b) the amount of those resources are equal to or greater than 4% of the APM Entity’s total Medicare Parts A and B revenues.

(3) Expected expenditures. For the purposes of this section, expected expenditures is defined as either:

(i) the payment to the APM entity, if the APM entity will be responsible for paying for all of the services to be delivered under the APM, or

(ii) the spending target established under the APM for the total spending on all of the services to which the APM applies.

(4) Capitation. A full capitation arrangement meets this Qualified APM criterion. For purposes of this subpart, a capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made to an APM Entity for all items and services furnished to a population of beneficiaries, and no settlement is performed to reconcile or share losses incurred or savings earned by the APM Entity. Arrangements made between CMS and Medicare Advantage Organizations under the Medicare Advantage program (42 U.S.C. section 422) are not considered capitation arrangements for purposes of this paragraph (c)(4).

(5) Medical Home Model Expanded under section 1115A(c) of the Act. A Medical Home Model that has been expanded under section 1115A(c) of the Act meets the financial risk criterion under this section.

Additional recommendations for changes in the proposed MACRA regulations are included in the Center for Healthcare Quality and Payment Reform’s formal comment letter to CMS on the proposed MACRA regulations, which can be downloaded here.

These changes to the regulations are necessary but not sufficient to accelerate the development and implementation of APMs. CMS also needs to significantly change the current process it uses to implement APMs, which is far too slow and burdensome. Recommendations for this are included in CHQPR’s comment letter to CMS and will be described in a future message.